Sarnova HC, LLC

Regulatory Specialist - Sarnova

US-OH-Dublin
ID
2017-2138
# of Openings
1
Category
Legal/Regulatory

Company Overview

Sarnova is the leading national specialty distributor of health care products in the emergency medical services (EMS) and respiratory markets. The company operates through several market-leading distributors including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and DXE Medical which specializes in AED’s and EKG’s.

 

We offer more 100,000 health care products to 20,000 hospitals and emergency care providers across the country. Sarnova is the only national distributor that can offer expertise and support across multiple specialty health care markets.

 

Responsibilities and Qualifications

Summary:

 

The Regulatory Specialist will be responsible for establishing and maintaining compliance with the VAWD, DEA & FDA process including distribution licensing as well as other responsibilities as assigned.

 

Essential Duties and Responsibilities:

  • Manage FDA, DEA, and state board of pharmacy licensing processes.
  • Renew applicable licenses for all subsidiaries including BTM & call centers, EMP, THS, and DXE. 
  • Responsible for all aspects of VAWD application, accreditation & renewal activities.
  • Draft Work Instruction for the VAWD accreditation process.
  • Support operations with costs and timeframes to license appropriate warehouses for desired shipping models.
  • Prepare warehouses for audit/inspections.
  • Perform audits throughout the business in accordance with our compliance program.
  • Collaborate with operations to develop and implement processes to fill gaps identified in audit findings, and law changes.
  • Serve as back up to assist in the regulatory activities for corporate acquisitions.
  • Assist in managing the company’s suspicious order monitoring program.
  • Prepare annual budget for licensing expenses and perform analysis periodically to report and reconcile any surplus or deficit.
  • Process department credit card transactions.

Qualifications:

  • Bachelor’s degree.
  • 5 to 8 years of quality or regulatory experience in the medical device or pharmaceutical industry.
  • Direct experience in the medical device or pharmaceutical industry desired.
  • Demonstrated familiarity with FDA, DEA and state regulations and the application of sound Quality Systems to ensure compliance.

Skills/Experience Required:

  • Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes.
  • Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies.
  • Strong written and verbal communication skills.
  • Well-developed organizational and cross functional skills.
  • Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software.

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled

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